Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries

May 18, 2024 updated by: Ahmed Atef Ahmed, Assiut University
The study is aimed to determine which of the two methods , either the fascia iliaca block or the caudal block is better in managing the post operative pain and by which decreasing the consumption of analgesic drugs post operatively and making the patient more comfortable.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site.(1) Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period.4,5 Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.6 Often, the donor site is reported to be more painful than the recipient site,7 affecting early mobilization, sleep, and need for analgesics postoperatively.(1) Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.(2) Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia.(2) Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves(3) American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.(4) Prolongation of analgesia after any surgery is the goal of any phsyician ,and Fascia Iliaca Block (FIB), which is widely used for postoperative analgesia in many surgeries, is a nerve block technique with proven efficacy. but which has the superior effect of numbing the pain ..Is it the fascia iliaca erve block or the caudal block .

The objective of this study is to compare post operative analgesic effect and safety of fascia iliaca nerve block versus caudal block in pediatric patient undergoing a graft surgery .

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 2- 12 years. ASA I - II Scheduled for split thickness grafting. Availability and suitability of lateral and anterior aspects of the thigh as a donor site.

Exclusion Criteria:

  • Patient's gaurdian refusal to participate in the study. Known allergy to local anesthetics Coagulopathy. Patient with motor or sensory deficits in lower extremities. Prior surgery of the inguinal or suprainguinal area . Children who are morbidly obese (BMI≥30) because ultrasound guided regional anesthesia could be too technically difficult.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fascia iliaca group
For the group who will receive the fascia iliaca block …. After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position after sterilization of skin over the groin area at the side from which split thickness graft will be taken, high frequency ultrasound probe
Drug: Fascia iliaca block
For the group who will receive the fascia iliaca block …. After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position
Active Comparator: Caudal block

And the second group will receive the caudal block, we use bupivacaine 0.5 mg / kg.

With the patient in the left lateral decubitus position and the hips and knees flexed, the sacral hiatus can be identified .First of all, the posterior superior iliac spines are palpated via anatomical landmarks, the line between both spines (Tuffier's line) representing the base of an equilateral triangle the tip of which indicates the position of the sacral hiatus. The sacrococcygeal ligament can be palpated between the two sacral cornua, which is where the needle should penetrate the skin at an approximate 45° angle. Once the ligament has been passed, a flatter angle is adjusted by descending the needle before it can be advanced to the correct final position.
Drug: Caudal block
second group will receive the caudal block, we use bupivacaine 0.5 mg / kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesia using FLACC score
Time Frame: 1-24 hour postiperative
Postoperative analgesia using FLACC score
1-24 hour postiperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

May 18, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 18, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • FB vs CB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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